Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma

Summary

Study No.001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy, can be equally controlled by guidelines recommended regular bid treatment with long acting beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol (experimental treatment) versus regular, twice daily 160/4.5 mcg inhaled budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended treatment).

Timeline

Start

2009-04

Primary completion

2013-04

Completion

2013-05

Publications

• Papi A, Marku B, Scichilone N, Maestrelli P, Paggiaro P, Saetta M, Nava S, Folletti I, Bertorelli G, Bertacco S, Contoli M, Plebani M, Barbaro MPF, Spanevello A, Aliani M, Pannacci M, Morelli P, Beghe B, Fabbri LM; AIFASMA Study Group. Regular versus as-needed budesonide and formoterol combination treatment for moderate asthma: a non-inferiority, randomised, double-blind clinical trial. Lancet Respir Med. 2015 Feb;3(2):109-119. doi: 10.1016/S2213-2600(14)70266-8. Epub 2014 Dec 4.

Drugs

Indications